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FLOW (Finding Lasting Options for Women) Multicentre Randomized Controlled Trial Comparing Tampons with Menstrual Cups

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FLOW (Finding Lasting Options for Women) Multicentre Randomized Controlled Trial Comparing Tampons with Menstrual Cups Research | Web exclusive FLOW (finding lasting options for women) Multicentre randomized controlled trial comparing tampons with menstrual cups Courtney Howard MD CCFP(EM) Caren Lee Rose MSc Konia Trouton MD CCFP MPH Holly Stamm MD CCFP Danielle Marentette MD CCFP Nicole Kirkpatrick MD CCFP(EM) Sanja Karalic MD CCFP MSc Renee Fernandez MD CCFP Julie Paget MD CCFP Abstract Objective To determine whether menstrual cups are a viable alternative to tampons. Design Randomized controlled trial. EDITOR’S KEY POINTS Setting Prince George, Victoria, and Vancouver, BC. • Patients are increasingly asking physicians about more environmentally friendly Participants A total of 110 women aged 19 to 40 years who had previously alternatives to disposable menstrual used tampons as their main method of menstrual management. management products, particularly menstrual cups, and about their Intervention Participants were randomized into 2 groups, a tampon group effectiveness compared with tampons. and a menstrual cup group. Using online diaries, participants tracked 1 Although the safety and efficacy of menstrual cycle using their regular method and 3 menstrual cycles using menstrual cups have been studied the method of their allocated group. previously, a randomized controlled trial comparing cups with tampons has never Main outcome measures Overall satisfaction; secondary outcomes been done. included discomfort, urovaginal infection, cost, and waste. • This study compared the experiences of Results Forty-seven women in each group completed the final survey, 5 of women using only tampons with women whom were subsequently excluded from analysis (3 from the tampon group using only menstrual cups over a period and 2 from the menstrual cup group). Overall satisfaction on a 7-point of 3 menstrual cycles; in terms of overall Likert scale was higher for the menstrual cup group than for the tampon satisfaction, study participants were as group (mean [standard deviation] score 5.4 [1.5] vs 5.0 [1.0], respectively; satisfied with menstrual cups as they were P = .04). Approximately 91% of women in the menstrual cup group said with tampons if not more satisfied, and they would continue to use the cup and recommend it to others. Women 91% said they would continue to use the used a median of 13 menstrual products per cycle, or 169 products per year, cup and recommend it to others. which corresponds to approximately 771 248 400 products used annually in Canada. Estimated cost for tampon use was $37.44 a year (similar to the • Although subjective vaginal discomfort retail cost of 1 menstrual cup). Subjective vaginal discomfort was initially was higher in menstrual cup users, this higher in the menstrual cup group, but the discomfort decreased with con- decreased with continued use and did tinued use. There was no significant difference in physician-diagnosed uro- not affect the prevalence of urovaginal vaginal symptoms between the 2 groups. symptoms. Women took advantage of the support offered in this study, suggesting Conclusion Both of the menstrual management methods evaluated were that there is a role for primary care well tolerated by subjects. Menstrual cups are a satisfactory alternative to providers in providing counseling to help tampons and have the potential to be a sustainable solution to menstrual optimize menstrual management. management, with moderate cost savings and much-reduced environmen- tal effects compared with tampons. • Menstrual cups are a comparable alternative to tampons; over the long Trial registration number C06-0478 (ClinicalTrials.gov). term, they are less costly and produce less environmental waste. This article has been peer reviewed. Cet article a fait l’objet d’une révision par des pairs. • The study was limited to a small group of Can Fam Physician 2011;57:e208-15 mostly white women over a relatively short period of time; further long-term study in This article is eligible for Mainpro-M1 credits. credits. To earn a more diverse population is required to Tocredits, earn credits,go to www.cfp.ca go to www.cfp.ca and click and on click the onMainpro the Mainpro link. link. confirm the generalizability of these results. e208 Canadian Family Physician • Le Médecin de famille canadien | VOL 57: JUNE • JUIN 2011 Exclusivement sur le web | Recherche Flux menstruel : à la recherche d’une alternative durable pour les femmes Essai clinique randomisé multicentrique comparant les tampons hygiéniques aux coupes menstruelles Courtney Howard MD CCFP(EM) Caren Lee Rose MSc Konia Trouton MD CCFP MPH Holly Stamm MD CCFP Danielle Marentette MD CCFP Nicole Kirkpatrick MD CCFP(EM) Sanja Karalic MD CCFP MSc Renee Fernandez MD CCFP Julie Paget MD CCFP Résumé POINTS DE REPÈRE DU RÉDACTEUR Objectif Déterminer si les coupes menstruelles constituent une solution • Les médecins reçoivent de plus en plus de de remplacement satisfaisante aux tampons hygiéniques. questions sur une façon de se débarrasser des produits de menstruation qui soit plus Type d’étude Essai clinique randomisé. respectueuse de l’environnement, comme par exemple l’utilisation des coupes menstruelles Contexte Prince George, Victoria et Vancouver, BC. et leur efficacité par rapport aux tampons hygiéniques. Même si l’efficacité et Participantes Un total de 110 femmes de 19 à 40 ans qui avaient l’innocuité des coupes menstruelles ont antérieurement utilisé surtout des tampons pour leurs menstruations. déjà été étudiées, il n’y a jamais eu d’essai clinique randomisé comparant les coupes aux Intervention Les participantes ont été assignées au hasard à 2 groupes, tampons. un groupe tampons et un groupe coupes menstruelles. Elles ont utilisé un journal en ligne pour inscrire des commentaires sur un premier cycle • Cette étude a comparé l’expérience de menstruel avec leur méthode habituelle et 3 autres cycles avec la méthode femmes qui, sur une période de 3 cycles menstruels, ont utilisé uniquement des choisie pour leur groupe. tampons à d’autres qui n’ont utilisé que des coupes; en termes de satisfaction globale, Principaux paramètres à l’étude Satisfaction globale; les issues celles du groupe coupe menstruelle étaient secondaires incluaient l’inconfort, les infections vaginales, le coût et la aussi, sinon plus satisfaites que celles du disposition des déchets. groupe tampon hygiénique, et 91 % d’entre elles ont déclaré qu’elles continueraient à Résultats Quarante-sept femmes de chaque groupe ont complété le utiliser les coupes et à le recommander à questionnaire final, dont 5 ont été subséquemment exclus de l’analyse (3 d’autres. du groupe tampons et 2 du groupe coupes menstruelles). Mesurée sur une échelle de Likert de 7 points, la satisfaction globale était plus élevée dans • Quoique les utilisatrices des coupes le groupe coupes menstruelles que dans le groupe tampons (moyenne rapportaient davantage d’inconfort vaginal, [écart type] 5.4 [1.5] vs 5.0 [1.0] respectivement; P = .04). Environ 91 % des ce problème diminuait avec le temps et femmes du groupe coupes menstruelles ont dit qu’elles continueraient à n’avait pas d’influence sur la prévalence des utiliser les coupes et à les recommander à d’autres. Les participantes ont symptômes uro-vaginaux . Les femmes ont utilisé une médiane de 13 produits menstruels par cycle, ou 169 produits bénéficié du support offert dans cette étude, par année, ce qui correspond à environ 771 248 400 produits par année ce qui laisse croire que les intervenants de au Canada. Le coût estimé pour utiliser des tampons était de 37,44 $ par première ligne ont un rôle à jouer pour aider année (semblable au prix de détail d’une coupe menstruelle). Il y avait à optimiser la gestion des menstruations. plus d’inconfort vaginal subjectif dans le groupe coupes menstruelles, mais ce problème diminuait avec l’usage. Il n’y avait pas de différence • Les coupes menstruelles représentent une significative entre les 2 groupes quant au taux de symptômes uro- solution de rechange à long terme aussi vaginaux diagnostiqués par un médecin. valable que les tampons; elles sont moins coûteuses et génèrent moins de déchets Conclusion Les 2 méthodes de gestion des menstruations évaluées environnementaux. étaient bien tolérées par les participantes. Les coupes menstruelles constituent une solution de rechange satisfaisante aux tampons et elles • Cette étude portait sur un groupe limité de sont susceptibles de représenter un solution à long terme pour la gestion femmes caucasiennes et sur une période des menstruations, avec un coût un peu moindre et beaucoup moins relativement courte; il faudra d’autres études d’effets sur l’environnement par rapport aux tampons. à long terme sur une population plus diversifiée pour que ces résultats puissent Numéro d’enregistrement de l’étude C06-0478 (ClinicalTrials.gov). être généralisés. VOL 57: JUNE • JUIN 2011 | Canadian Family Physician • Le Médecin de famille canadien e209 Research | FLOW (finding lasting options for women) am using tampons right now, but I would like to from November 2006 to September 2007. They were try a menstrual cup. Do they work as well as tam- recruited via posters in family practice offices, e-mail I pons?” This patient query is becoming more com- lists, and stories in local media. Women between 19 and mon. Menstrual cups are flexible, reusable cups made 40 years of age with monthly menstrual flow who used of rubber or silicone that are worn intravaginally to col- tampons as their primary method of menstrual manage- lect menstrual flow.1 Interest in their use is increasing, ment were eligible. Exclusion criteria were sensitivity largely because of public desire for more environmen- or allergy to silicone, active vaginal or urogenital infec- tally friendly menstrual products.2 tion, pregnancy or plans to become pregnant before the Studies on tampons show that they are well toler- end of the study, use of systemic antimicrobials within ated.3,4 There is no conclusive evidence that tampons sub- the previous 14 days, inability to understand the nature stantially affect rates of vaginitis or urinary tract infection and purpose of the study, and inability to understand (UTI).5-10 Independent research in the 1980s found toxic and express themselves in written and spoken English.
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